ECA Group Update May through August 2022
The ECA Foundation's Interest Groups have summarised in their report again what they were working in and accomplished in the four months from May through August 2022.
European QP Association (EQPA)
The Board will meet face-to-face in early December in Berlin (after the QP Forum).
White Paper on Annex 21 and fiscal importation
The EQPA has published a paper in the download section of the members’ area discussing “Developments on GMP classification of fiscal imports”. Background: The potential need for an Annex 21, finally published in February 2022, was identified during the development of Annex 16 – when the authors concluded that not all topics around importation could be clarified. One dominant and main driver for the new Annex 21 is thus the existence of fiscal importation and whether such concepts of international money transactions crossing outside boarders of the EU should be handled according to GMP regulations or not. The issue was legally complex. Annex 16 was cleared to be published in 2016, the solution on fiscal importation was expected to come with Annex 21. It did not. For more details please see the background article in the members' area of the EQPA website.
Survey on Contract QP Activities
According to Article 48 of Directive 2001/83/EC each manufacturer has to have at his disposal at least one Qualified Person. There are no details on the contractual arrangement for this “disposal of services”, though.
As QPs in many member states offer their service as independent entrepreneurs and “contract QPs”, these states have developed rules and expectations posed on independent QPs usually without own MIA. Therefore, EQPA has sent out a survey in April to find out more about this area of QP activities, which is not harmonized within the EU. With more than 350 QPs participating, this is a high response rate for such a specific survey topic. One third of the responses provided came from contracted QPs. The results were published in the members’ area on EQPA’s website. as well as in the EQPA Newsletter issue from June 2022.
Draft Act to amend Annex VI to Clinical Trial Regulation (EU)
On 01 June 2022 the Commission launched a Draft Act to amend Annex VI to Clinical Trial Regulation (EU) No 536/2014. As outlined on the Commission’s website, “this initiative eliminates the obligation to include an expiry date on the immediate packaging of unauthorised medicinal products used in clinical trials in specific circumstances (e.g., on syringes). The aim is to prevent additional safety and quality risks associated with the relabelling procedure and the need for more frequent re-supply, which may lead to delays in clinical trials.”
The EQPA’s IMP Working Group has asked members for feedback to enable the group to provide consolidated feedback from the IMP Working Group/ European QP Association.
Overall, the IMP Working Group appreciates the ongoing revision of Annex VI to Clinical Trial Regulation (EU) No 536/2014 and agrees that re-labelling procedures of immediate packaging would add significant safety and quality risks to clinical trial medication. Comments were sent to the EU Commission.
National requirements for QPs beyond EU requirements
EU law is built on parent acts including directive 2001/83/EC and since end of January 2022 the Regulations 536/2014 on Clinical Trials (CTR) and Regulation 2019/6 on Veterinary Medicines (VMR). EudraLex Volume 4 includes a common interpretation of how to comply with EU legislative expectations. The specific responsibilities of the QP are not really numerous as defined in directive 2001/83/EC. However, the EQPA knows from discussions and previous surveys that countries may add specific additional requirements and personal responsibilities for QPs beyond this directive and the GMP Guides.
With this survey sent out end of July with a reminder end of August, the EQPA was looking for more insight in this. Results should also support argumentation for a better harmonisation across the Member States.
QP Education Course in Copenhagen
For the first time after more than two years of live online trainings, the QP Education Course (Module B) was held live on-site again (02/03 June 2022, Copenhagen, with a pre-course session on 01 June). Altogether 30 delegates have attended (15 for the Education Course and 15 both the Education Course plus the pre-course session). According to the feedback, delegates enjoyed asking questions live and the discussions. The overall average rating of the pre-course session on Soft Skills was 1.2 (1 = very good, 6 = bad). The overall average rating of the QP Education Course was 1.45.
EMA has opened a short 1-month public consultation on a draft set of Questions and Answers on remote batch certification by the Qualified Persons. Ulrich Kissel has created a consolidated EQPA feedback document which has also taken into account feedback received by EQPA members. Details were discussed during a face-to-face meeting in the course of the QP Education Course in Copenhagen. Consolidated comments were sent to EMA.
The EQPA is working with other stakeholders on an industry follow-up on COVID-19 & supply chain activities: As a follow-up of the EMA-IWG-Industry meeting, industry would like to provide to the IWG the feedback on the EMA-IWG action item: ‘The Interested Parties are invited to provide suggestions for consideration by IWG on potential alternative measured to manage expiring GMP-certificates at the end of 2022’.
A paper for the EMA GMP/GDP IWG on Qualified Persons (art. 48 of Directive 2001/83/EC) Practical Experience Requirements was prepared by the EQPA/ECA (lead) and EFPIA. During the meeting of the GMP/GDP IWG meeting with Interested Parties, on 10 March 2022, the lack of harmonisation in the interpretation and transposition of the practical experience requirements for Qualified Persons (QPs) laid down in EU legislation was presented. A proposal was therefore made to harmonise approaches, for example through guidelines. The Commission’s representative at the meeting invited the Interested Parties to submit a proposal directly to the Commission in the context of the ongoing revision of the EU general pharmaceuticals legislation. EQPA, together with ECA Foundation (ECA) and EFPIA wrote a problem statement with a detailed proposal and rationale.
Find out more about the current courses & conferences programme organized and co-sponsered by the European QP Association.
Pharmaceutical Microbiology Group
A board meeting has been scheduled to take place at the end of November at PharmaLab 2022.
The draft of the chapter on Identification of the Deviation Guide has been reviewed – and the authors are working on the analysis of the comments.
Take a look at the current courses & conferences programme in pharmaceutical microbiology.
The Board set up a meeting on-site for mid of November 2022.
The sub-groups have started to update their chapters of the Group's Good Practice Guide Integrated Qualification and Validation Guide. The sub-group covering electronic documentation received a big interest. This group had exchanged their results with ECA´s Data Integrity and IT Compliance Group. Its head, Dr. Wolfgang Schumacher, has reviewed the electronic documentation chapter. The development of a version 2.2 of the Integrated Qualification and Validation Guide is in progress and will be published at the Qualification and Validation Forum mid of November 2022 in Heidelberg, Germany.
In addition to courses on Process Validation, Cleaning Validation, Process Understanding and on Ongoing/Continued Process Verification online and on-site, the Qualification and Validation Forum end of Nov replaces the Launch Conferences.
Find out more about the current validation courses & conferences programme.
European GDP Association
Afshin Hosseiny, who has been the European GDP Association's Advisory Board Chairman since its foundation, has decided to step down from this position. For this reason, Alfred Hunt joined as the Deputy Chair in 2021. After a year of the two working together, Alfred Hunt has taken over the role as the Chairman in June 2022. Afshin Hosseiny left the Board, but as he is also Chairman of the ECA Executive Board, he will continue to support the activities of the European GDP Association.
Further, Prabjeet Dulai has resigned from her position of Director of Regulatory Affairs and Communication and left the GDPA Board. She has also withdrawn from the ECA speakers' panel.
The annual board meeting took place mid of June 2022. Like in the year before, the meeting was held online. The next board meeting is scheduled to take place in June 2023.
A report with actions was finalised and circulated among the members. Moreover, the GDPA business plan was updated, the objective was reformulated.
Markus Funk has prepared an article on “Common and Typical GDP Violations – an Evaluation of GDP Non-Compliance Reports since 2014” for the GMP Journal.
The second GMP & GDP Forum is planned to take place in 2023. The group started to plan the content and discussed ideas. Possible external speakers were contacted/invited.
Get an overview of the current GDP events.
The board of the Group invited Dr Ulrike Herbrand to join as Bioassay Expert.
A board meeting has been scheduled for mid of October.
Please also take a look at the events programme concentrating on ATMP topics.
Data Integrity & IT Compliance Group
Version 3 of the DI guide is ready and will be published after a revision of the references.
Here you will get to the courses and conferences focusing on data integrity & IT compliance issues.